Investigation of the efficacy and safety of preoperative IOP reduction with preservative-free COSOPT-S® (dorzolamide/timolol, MSD) eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma patients - COSOPT-S® Study

Conditions: Patients with glaucoma requiring trabeculectomy (filtration surgery)
MedDRA version: 12.1Level: LLTClassification code 10018304Term: Glaucoma
MedDRA version: 12.1Level: LLTClassification code 10050156Term: Glaucoma surgery

Registration Number: EUCTR2010-019975-30-DE

Lead Sponsor: niversity Medical Center, Johannes Gutenberg-University Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Male or female patients aged 18 years or older
•Caucasian
•A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
•Previous treatment with antiglaucoma agents containing preservatives for at least one month
•Best corrected visual acuity of 20/800 or better in the study eye

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
•Current ocular infection, i.e. conjunctivitis or keratitis
•Any abnormality preventing reliable applanation tonometry
•Intraocular surgery or laser treatment within the past three months
•History of surgery involving the conjunctiva
•History of cataract surgery with sklerocorneal approach
•Subject is allergic to sulfonamides
•Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
•Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
•Severe renal dysfunction (CrCl < 30 ml/min) or hyperchloraemic acidosis
•History of hypersensitivity to the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that COSOPT-S® b.i.d is not inferior to the standard regimen in terms of IOP reduction three months after trabeculectomy.;Secondary Objective: •To show that the tolerability and safety of COSOPT-S® b.i.d. is descriptively superior to that of reference therapy<br>•Comparison of the regimen COSOPT-S® b.i.d. with the reference regimen in terms of postoperative complications and the filtration bleb status three months after trabeculectomy<br>•Exploration of patients’ satisfaction and health care utilisation<br>;Primary end point(s): Mean IOP reduction (?IOP) three months after trabeculectomy in comparison to the mean preoperative IOP

Secondary Outcome Measures